NCT03255382已完成3 期
A Randomized, Controlled, Multicenter, Open Label Study With Blinded Assessment of the Efficacy of the Humanized Anti-IL-23p19 Risankizumab Compared to FUMADERM® in Subjects With Moderate to Severe Plaque Psoriasis Who Are Naïve to and Candidates for Systemic Therapy
AbbVie23 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2017年8月22日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 23
- 主要终点
- Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI90) at Week 24
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of subcutaneous (SC) risankizumab and oral FUMADERM provided as study medication in participants with moderate to severe plaque psoriasis who are naïve to and candidates for systemic therapy.
详细描述
The efficacy analysis was performed in the Intent to Treat (ITT) set which included all participants who were randomized. The safety analysis was performed in the safety set which included all participants who received at least one dose of study drug. No participants were excluded from the efficacy analysis. Three participants in the FUMADERM® group discontinued after randomization prior to receiving any study drug and were thus not included in the safety set.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a diagnosis of chronic plaque psoriasis for at least 6 months before the first administration of study drug. Duration since diagnosis may be reported by the participant
- •Participant has stable moderate to severe plaque psoriasis (body surface area [BSA] >10, Psoriasis Area and Severity Index [PASI] >10, and Dermatology Quality of Life Index [DLQI] >10) with or without psoriatic arthritis at Baseline
- •Must be naïve to and candidate for systemic therapy, as assessed by the investigator
- •Participant has an inadequate response, intolerance or contraindication to topical psoriasis treatment
排除标准
- •Participants with non-plaque forms of psoriasis
- •Participant has previously received systemic therapy for psoriasis, whether biologic or non-biologic or photochemotherapy
- •Active systemic infection during the last 2 weeks (exception: common cold) prior to screening.
- •Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix
- •Participant has any condition or contraindication to Fumaderm that would preclude the patient's participation in the present study
研究组 & 干预措施
Fumaderm
Active Comparator
Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2 and then up to 240 mg, 3 times daily from Week 3 to Week 24 if 90% Improvement in Psoriasis Area and Severity Index (PASI90) is not achieved and if tolerability allows.
干预措施: Fumaderm (Drug)
Risankizumab
Experimental
Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.
干预措施: risankizumab (Drug)
结局指标
主要结局
Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI90) at Week 24
时间窗: Week 24
The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. Non-responder imputation (NRI) was used for missing data.
次要结局
- PASI: Change From Baseline to Week 16(Baseline, Week 16)
- Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 8(Week 8)
- Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 12(Week 12)
- Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 16(Week 16)
- Percentage of Participants Achieving sPGA Score of Clear at Week 8(Week 8)
- Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 20(Week 20)
- Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 24(Week 24)
- Percentage of Participants Achieving sPGA Score of Clear at Week 4(Week 4)
- Percentage of Participants Achieving sPGA Score of Clear at Week 12(Week 12)
- Percentage of Participants Achieving sPGA Score of Clear at Week 16(Week 16)
- Percentage of Participants Achieving sPGA Score of Clear at Week 20(Week 20)
- Percentage of Participants With PSS Score of 0 at Week 24(Week 24)
- Percentage of Participants Achieving sPGA Score of Clear at Week 24(Week 24)
- Percentage of Participants With Psoriasis Symptoms Scale (PSS) Score of 0 at Week 16(Week 16)
- Summary of Patient Benefit Index (PBI) at Week 16(Baseline, Week 16)
- NAPPA-CLIN Total Score: Change From Baseline to Week 24(Baseline, Week 24)
- PPASI: Change From Baseline to Week 24(Baseline, Week 24)
- PSS Total Score: Change From Baseline to Week 16(Baseline, Week 16)
- PSS Total Score: Change From Baseline to Week 24(Baseline, Week 24)
- Clinical Severity of Nail Psoriasis (NAPPA-CLIN) Total Score: Change From Baseline to Week 16(Baseline, Week 16)
- Summary of PBI at Week 24(Baseline Week 24)
- Palmoplantar Psoriasis Severity Index (PPASI): Change From Baseline to Week 16(Baseline, Week 16)
- Body Surface Area (BSA) Affected by Psoriasis: Change From Baseline to Week 4(Baseline, Week 4)
- Patient's Global Assessment (PtGA): Change From Baseline to Week 16(Baseline, Week 16)
- PtGA: Change From Baseline to Week 24(Baseline, Week 24)
- HADS Total Score-Anxiety: Change From Baseline to Week 24(Baseline, Week 24)
- BSA Affected by Psoriasis: Change From Baseline to Week 8(Baseline, Week 8)
- BSA Affected by Psoriasis: Change From Baseline to Week 12(Baseline, Week 12)
- BSA Affected by Psoriasis: Change From Baseline to Week 24(Baseline, Week 24)
- SF-36 V2 PCS Score: Change From Baseline to Week 24(Baseline, Week 24)
- BSA Affected by Psoriasis: Change From Baseline to Week 16(Baseline, Week 16)
- BSA Affected by Psoriasis: Change From Baseline to Week 20(Baseline, Week 20)
- Short Form Health Survey 36, Version 2 (SF-36 V2) Physical Component Summary (PCS) Score: Change From Baseline to Week 16(Baseline, Week 16)
- SF-36 V2 Mental Component Summary (MCS) Score: Change From Baseline: to Week 16(Baseline, Week 16)
- SF-36 V2 MCS Score: Change From Baseline to Week 24(Baseline, Week 24)
- Hospital Anxiety & Depression Scale (HADS) Total Score-Anxiety: Change From Baseline to Week 16(Baseline, Week 16)
- HADS Total Score-Depression: Change From Baseline to Week 24(Baseline, Week 24)
- HADS Total Score-Depression: Change From Baseline to Week 16(Baseline, Week 16)
- DLQI Total Score: Change From Baseline to Week 16(Baseline, Week 16)
- Psoriasis Scalp Severity Index (PSSI): Change From Baseline at Week 16(Baseline, Week 16)
- EQ-5D-5L Visual Analog Scale (VAS): Change From Baseline to Week 16(Baseline, Week 16)
- Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16(Week 16)
- DLQI: Change From Baseline to Week 24(Baseline, Week 24)
- Percentage of Participants Achieving DLQI Score of 0 or 1 at Week 24(Week 24)
- PSSI: Change From Baseline at Week 24(Baseline, Week 24)
- European Quality of Life 5 Dimensions (EQ-5D-5L) Total Score: Change From Baseline to Week 16(Baseline, Week 16)
- EQ-5D-5L Total Score: Change From Baseline to Week 24(Baseline, Week 24)
- Participants With Baseline NAPSI ˃0: Change From Baseline to Week 16(Baseline, Week 16)
- EQ-5D-5L VAS: Change From Baseline to Week 24(Baseline, Week 24)
- NAPSI: Change From Baseline to Week 24(Baseline, Week 24)
- Participants With Baseline NAPSI ˃0: Change From Baseline to Week 24(Baseline, Week 24)
- Nail Psoriasis Severity Index (NAPSI): Change From Baseline to Week 16(Baseline, Week 16)
- Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 16(Week 16)
- Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 4(Week 4)
- Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 12(Week 12)
- Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 8(Week 8)
- Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 24(Week 24)
- Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 16(Week 16)
- Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 20(Week 20)
- Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 8(Week 8)
- Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 12(Week 12)
- Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 20(Week 20)
- Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 4(Week 4)
- Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 4(Week 4)
- Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 24(Week 24)
- Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 12(Week 12)
- Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 20(Week 20)
- Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 24(Week 24)
- Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 8(Week 8)
- Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 16(Week 16)
- Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 20(Week 20)
- Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 16(Week 16)
- PASI: Change From Baseline to Week 8(Baseline, Week 8)
- Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 4(Week 4)
- Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 4(Week 4)
- PASI: Change From Baseline to Week 12(Baseline, Week 12)
- Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 8(Week 8)
- Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 12(Week 12)
- Psoriasis Area and Severity Index (PASI): Change From Baseline to Week 4(Baseline, Week 4)
- PASI: Change From Baseline to Week 20(Baseline, Week 20)
- PASI: Change From Baseline to Week 24(Baseline, Week 24)
研究者
研究点 (23)
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